Director of Sterility Assurance

<p>The Director of Sterility Assurance is accountable for defining, implementing, and sustaining the sterility assurance and contamination control strategy for autologous cell therapy manufacturing operations supporting clinical and commercial programs at ProKidney.</p> <p>This role provides strategic and operational leadership for aseptic processing, contamination control, environmental monitoring, cleanroom operations, microbiological quality systems, and inspection readiness across centralized manufacturing activities associated with autologous renal cell therapy products.</p> <p>The Director will ensure compliance with FDA, EMA, and global GMP expectations for sterile and aseptic manufacturing, with particular emphasis on the unique risks associated with patient-specific autologous manufacturing, open manipulations, short manufacturing timelines, cryopreservation, and chain-of-identity/chain-of-custody controls.</p> <p>This individual will serve as a key technical and quality leader supporting BLA readiness, process validation, commercial launch preparation, and pre-approval inspection (PLI) activities.</p> <p><strong>Key Responsibilities</strong></p> <p><strong>Sterility Assurance & Contamination Control Strategy</strong></p> <ul> <li>Define, own, and govern the enterprise contamination control strategy (CCS) for autologous cell therapy manufacturing operations.</li> <li>Serve as an SME for sterility assurance, aseptic processing, and contamination control in cell therapy manufacturing environments.</li> <li>Establish risk-based microbial control strategies tailored to autologous manufacturing workflows and patient-specific processing.</li> <li>Ensure alignment of sterility assurance programs with:</li> </ul> <ul> <ul> <li>FDA aseptic processing guidance</li> <li>EU GMP Annex 1</li> <li>ATMP expectations</li> <li>applicable ICH guidance</li> </ul> </ul> <p><strong>Autologous Cell Therapy Manufacturing Support</strong></p> <ul> <li>Provide oversight of aseptic manufacturing operations involving:</li> </ul> <ul> <ul> <li>patient-derived starting materials</li> <li>open and semi-closed manipulations</li> <li>biosafety cabinet operations</li> <li>cryopreservation activities</li> <li>final product handling and fill activities</li> </ul> </ul> <ul> <li>Define sterility-assurance requirements for manufacturing strategies that minimize operator intervention and contamination risk.</li> <li>Review and approve aseptic process workflows, interventions, and operator practices.</li> <li>Partner with Manufacturing and QC Micro to optimize contamination control during process scale-out and technology transfer.</li> </ul> <p><strong>Environmental Monitoring & Cleanroom Oversight</strong></p> <ul> <li>Support the strategy for environmental monitoring (EM) programs across GMP cleanrooms and classified processing environments.</li> <li>Ensure robust trending and investigation of:</li> </ul> <ul> <ul> <li>viable and non-viable EM excursions</li> <li>personnel monitoring results</li> <li>contamination events</li> <li>aseptic process deviations</li> </ul> </ul> <ul> <li>Establish scientifically justified alert/action levels and escalation procedures.</li> <li>Oversee cleanroom qualification and ongoing state-of-control assessments.</li> </ul> <p><strong>Aseptic Process Simulation & Validation</strong></p> <ul> <li>Lead strategy for media fills / aseptic process simulations (APS) representative of autologous manufacturing operations.</li> <li>Ensure APS programs appropriately model:</li> </ul> <ul> <ul> <li>extended manipulations</li> <li>worst-case interventions</li> <li>operator variability</li> <li>low-volume processing</li> <li>cryogenic handling steps</li> </ul> </ul> <ul> <li>Support qualification and validation activities for:</li> </ul> <ul> <ul> <li>biosafety cabinets</li> <li>isolators (if applicable)</li> <li>incubators</li> <li>cryostorage systems</li> <li>single-use manufacturing systems</li> <li>sterilizing filtration processes</li> </ul> </ul> <p><strong>Chain of Identity / Chain of Custody Risk Control</strong></p> <ul> <li>Collaborate cross-functionally to ensure contamination control strategies are integrated with:</li> </ul> <ul> <ul> <li>chain-of-identity systems</li> <li>chain-of-custody controls</li> <li>material segregation procedures</li> <li>patient-specific manufacturing safeguards</li> </ul> </ul> <ul> <li>Assess operational risks associated with multi-product and multi-patient processing environments.</li> </ul> <p><strong>Regulatory Inspection Readiness</strong></p> <ul> <li>Serve as the sterility assurance SME during:</li> </ul> <ul> <ul> <li>FDA inspections</li> <li>pre-license inspections (PLI)</li> <li>partner audits</li> <li>regulatory agency interactions</li> </ul> </ul> <ul> <li>Support preparation of regulatory filings and responses related to sterility assurance